4SC provides Q3 business update and outlook

17.10.2019 / 07:30
The issuer is solely responsible for the content of this announcement.

4SC provides Q3 business update and outlook

Significant progress made in Q3

Planegg-Martinsried, Germany, 17 October 2019 - 4SC AG (4SC, FSE Prime Standard: VSC) today provided a business update for the three months ended 30 September 2019, as well as its current outlook. The full report is available for download on 4SC's website.

Key highlights of Q3 2019 and beyond

4SC made significant progress in Q3 with its pipeline - currently comprising three clinical studies and two drug candidates, resminostat and domatinostat

4SC completed an initial capital increase raising EUR11 million in new funds and initiated a second capital raise for an additional EUR22.5 million which has been underwritten by its two largest shareholders

Completion of these capital increases will provide sufficient funds for the Company to execute on its programs out as far as the second half of 2021

4SC entered into a clinical collaboration with the Netherlands Cancer Institute (NKI) in Amsterdam for the DONIMI clinical study evaluating domatinostat in combination with checkpoint blockade as neoadjuvant therapy in melanoma

Jason Loveridge, Ph.D., CEO of 4SC, said: "We made very significant progress in the third quarter across the whole business. Most importantly, we presented highly encouraging data supporting the safety and efficacy of domatinostat in combination with checkpoint blockade in checkpoint non-responding and refractory melanoma patients, secured our financial future for the next two years, and can now initiate the next phase of our clinical program for domatinostat having secured the support of the NKI for neoadjuvant melanoma. We are now really well positioned to continue generate new data for the coming years and move our two drug candidates towards market entry."

Business outlook

Recruitment of at least the first 150 patients in the pivotal RESMAIN study of resminostat in CTCL in 2019. By around the middle of 2020 4SC expects to accumulate sufficient events - i.e. patients experiencing disease progression - required to unblind the study. Top-line results from the study would be available as soon as possible thereafter.

Results of Yakult Honsha's Phase II study of resminostat in biliary tract cancer expected to be available in the first half of 2020

Initiation of the MERKLIN 2 Phase II clinical study in Q4 2019

Initiation of the DONIMI Phase II clinical study in Q4 2019

Initial data from the phase Ib part of the EMERGE Phase Ib/II clinical study in Q1 2020

Out-licensed Programs

In Q3 2019, 4SC received milestone payments from its cooperation partners Guangzhou Link Health Pharma Co., Ltd and Maruho Co., Ltd. in accordance with license and development agreements entered into in 2016, respectively 2017.

Cash balance development in Q3 2019 and financial forecast

As of 30 September 2019, 4SC holds cash balance/-funds of EUR26,443 thousand as compared to EUR17,751 thousand as of 30 June 2019. The increase is a result of the capital increase in July as described above. The monthly use of cash from operations was below the range forecasted for 2019 amounting to EUR1,016 thousand on average in the first nine months of 2019 (9M 2018: EUR1,173 thousand).

The monthly use of cash from operations in the first nine months of 2019 was mainly driven by costs for the ongoing clinical studies RESMAIN and SENSITIZE.

Based on current financial and operating activities, the Management Board is expecting a lower average monthly cash burn rate from operations of between EUR1,300 thousand and EUR1,600 thousand for 2019 as compared to the earlier assumptions of EUR1,800 thousand to EUR2,000 thousand. The Management Board of 4SC confirms that the funds including proceeds from the capital increase as announced in October 2019, should be sufficient to finance 4SC into the second half of 2021.

4SC AG is a clinical-stage biopharmaceutical company developing small-molecule drugs that can target key indications in cancer with high unmet medical needs. 4SC's pipeline is protected by a comprehensive portfolio of patents and currently comprises two drug candidates in clinical development: resminostat and domatinostat.

4SC aims to generate future growth and enhance its enterprise value by entering into partnerships with pharmaceutical and biotech companies and/or the eventual marketing and sales of approved drugs in select territories by 4SC itself.

4SC is headquartered in Planegg-Martinsried near Munich, Germany. The Company had 47 employees as of 30 September 2019 and is listed on the Prime Standard of the Frankfurt Stock Exchange (FSE Prime Standard: VSC; ISIN: DE000A14KL72).

Forward-looking information

Information set forth in this press release contains forward-looking statements, which involve risks and uncertainties. The forward-looking statements contained herein represent the judgement of 4SC as of the date of this press release. Such forward-looking statements are neither promises nor guarantees but are subject to a variety of risks and uncertainties, many of which are beyond 4SC's control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. 4SC expressly disclaims any obligation or undertaking to release any updates or revisions to any such statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based.

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